VALENCIA, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced it has submitted its response to the U.S. Food and Drug Administration (FDA) for additional information requested in connection to its premarket approval (PMA) supplement for RECELL GO™. This submission resumes the substantive interactive review process under the Br ...

AVITA Medical, Inc. (NASDAQ:RCEL) Q4 2023 Earnings Conference Call February 22, 2024 4:30 PM ET Company Participants Jessica Ekeberg - Director, IR Jim Corbett - CEO David O'Toole - CFO Conference Call Participants Brooks O'Neil - Lake Street Capital Markets Ross Osborne - Cantor Fitzgerald Ryan Zimmerman - BTIG Chris Kallos - MSTF Madeleine Williams - Wilsons Lyanne Harrison - Bank of America Operator Good day and thank you for standing by. Welcome to the AVITA Medical Fourth Quarter 2023 Earnings Call. At ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of i ...

VALENCIA, Calif., Feb. 01, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices and autologous cellular therapies for skin restoration, today announced that it will report its fourth quarter and full year 2023 financial results after the close of the U.S. financial markets on Thursday, February 22, 2024. AVITA Medical will host a conference call and webcast that day at 1:30 p.m. Pacific Time (Friday, Februar ...

VALENCIA, Calif., Jan. 10, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))) (the "Company"), a commercial-stage regenerative medicine company focused on first-in-class devices and autologous cellular therapies for skin restoration, today announced it has entered into an exclusive multi-year distribution agreement with Stedical Scientific, Inc. to commercialize PermeaDerm® Biosynthetic Wound Matrix in the United States. PermeaDerm is cleared by the Food and Drug Administration as a tran ...

VALENCIA, Calif., Jan. 10, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))) (the "Company"), a commercial-stage regenerative medicine company focused on first-in-class devices and autologous cellular therapies for skin restoration, today announced preliminary unaudited financial highlights for the fourth quarter and full-year 2023, provided financial guidance for the first quarter and full-year 2024, and announced completion of patient enrollment in its post-market study, TONE. Prelimi ...

AVITA Medical, Inc. (NASDAQ:RCEL) Q3 2023 Results Conference Call November 9, 2023 4:30 PM ET Company Participants Jessica Ekeberg - Director of Investor Relations Jim Corbett - Chief Executive Officer David O’Toole - Chief Financial Officer Conference Call Participants Joshua Jennings - Cowen Brooks O'Neil - Lake Street Capital Markets John Hester - Bell Potter Ross Osborne - Cantor Fitzgerald Madeline Williams - Wilsons Operator Good day, and thank you for standing by. Welcome to the AVITA Medical Third Q ...

Financial Performance - Revenues for the three months ended September 30, 2023, were $13,645,000, a 50.1% increase from $9,092,000 in the same period of 2022[16] - Gross profit for the nine months ended September 30, 2023, was $29,964,000, compared to $20,272,000 for the same period in 2022, reflecting a 47.9% increase[16] - Operating loss for the three months ended September 30, 2023, was $9,306,000, compared to a loss of $5,748,000 in the same period of 2022, indicating a 62.5% increase in losses[16] - Net loss for the nine months ended September 30, 2023, was $28,316,000, compared to $21,312,000 for the same period in 2022, representing a 33% increase in net losses[16] - Net loss for the nine months ended September 30, 2023, was $28.316 million, compared to a net loss of $21.312 million for the same period in 2022, representing a 33.9% increase in losses[27] - The net loss for the three months ended September 30, 2023, was $8.712 million, compared to a net loss of $5.588 million for the same period in 2022, representing a 56.5% increase in losses[84] - The basic and diluted net loss per share for the three months ended September 30, 2023, was $0.34, up from $0.22 in the same period of 2022, indicating a 54.5% increase[84] Assets and Liabilities - Total current assets decreased to $73,927,000 as of September 30, 2023, from $87,458,000 as of December 31, 2022, a decline of 15.4%[14] - Total liabilities increased to $17,407,000 as of September 30, 2023, compared to $12,967,000 as of December 31, 2022, reflecting a 34.5% increase[14] - Stockholders' equity decreased to $62,978,000 as of September 30, 2023, from $84,740,000 as of December 31, 2022, a decline of 25.7%[14] - Cash and cash equivalents rose to $50,854,000 as of September 30, 2023, up from $18,164,000 as of December 31, 2022, a significant increase of 179.5%[14] - Cash used in operations for the nine months ended September 30, 2023, was $27.148 million, up from $15.654 million in the prior year, indicating a 73.5% increase in cash outflow[27] - As of September 30, 2023, cash and cash equivalents amounted to $4.4 million, with cash equivalents primarily in money market funds totaling $46.4 million[46] - Total current marketable securities as of September 30, 2023, were valued at $9.3 million, with U.S. Treasury securities contributing $5.4 million[51] - The Company reported a net unrealized loss of $20,000 on marketable securities as of September 30, 2023, compared to a net unrealized loss of $426,000 as of December 31, 2022[53] - The Company has accrued interest income of $228,000 as of September 30, 2023, compared to $168,000 as of December 31, 2022[53] Revenue Sources - The company reported BARDA income of $212,000 for the three months ended September 30, 2023, down from $904,000 in the same period of 2022, a decrease of 76.5%[16] - The Company recognized $90,000 and $250,000 in revenue from BARDA for the three-months and nine-months ended September 30, 2023, respectively, compared to $93,000 and $279,000 for the same periods in 2022[62] - Estimated revenue from remaining performance obligations is $469,000 as of September 30, 2023, down from $698,000 as of December 31, 2022, with a notable portion related to the BARDA contract[59] Research and Development - Research and development expenses for the nine months ended September 30, 2023, were $14,056,000, compared to $10,478,000 for the same period in 2022, an increase of 34.7%[16] Stock and Compensation - Total stock-based compensation for the nine months ended September 30, 2023, was $6.213 million, compared to $5.782 million in the prior year, marking a 7.5% increase[27] - Stock-based compensation expense for the three-months ended September 30, 2023, was $2.4 million, compared to $1.4 million in 2022, a 71.4% increase[78] - The Company’s total common stock increased to 25,550,694 shares by September 30, 2023, from 25,030,902 shares a year earlier, reflecting a growth of 2.1%[24] - The Company had a payout of approximately $753,000 in the deferred compensation liability for terminated employees during the third quarter of 2023[87] Operational Changes - The Company received FDA approval for the RECELL System for full-thickness skin defects on June 7, 2023, and commenced commercial launch on June 8, 2023[30] - The FDA approved a PMA application for the repigmentation of stable depigmented vitiligo lesions on June 16, 2023, with a post-market study expected to be completed by the end of 2024[31] - The company submitted a PMA supplement for RECELL GO™ on June 29, 2023, with a complete response to the FDA expected by February 28, 2024, potentially leading to a product launch on May 31, 2024[32] Inventory and Assets Management - Total inventory increased to $4,377,000 as of September 30, 2023, compared to $2,125,000 as of December 31, 2022, reflecting growth in raw materials, work in process, and finished goods[67] - The Company recorded charges for estimated excess and obsolescence in inventory of $81,000 for the three-months ended September 30, 2023, compared to $125,000 for the same period in 2022[67] - Total plant and equipment, net increased to $1,862,000 as of September 30, 2023, from $1,200,000 as of December 31, 2022, representing a 55.0% increase[70] - Depreciation expense for the three-months ended September 30, 2023, was $156,000, up from $130,000 for the same period in 2022, a 20.0% increase[70] Lease and Other Liabilities - Operating lease liabilities increased to $2,749,000 as of September 30, 2023, from $918,000 as of December 31, 2022, due to new lease agreements[66] - Other current liabilities increased to $1,341,000 as of September 30, 2023, from $990,000 as of December 31, 2022, a 35.4% increase[73] Future Financial Planning - The Company entered into a Credit Agreement on October 18, 2023, providing a five-year senior secured credit facility of up to $90 million, with an initial borrowing of $40 million[95] - The Company issued a warrant to purchase up to 409,661 shares of common stock at an exercise price of $10.9847 per share as part of the Credit Agreement[96] - The Company expects future amortization expenses for intangible assets to total $405,000, with $9,000 expected for the remainder of 2023[69]

Financial Data and Key Metrics Changes - The company reported commercial revenues of $11.7 million for Q2 2023, representing a 42% increase compared to $8.2 million in the same period in 2022, and at the top end of the guidance range of $10.7 million to $11.7 million [26][60] - The gross profit margin was 81%, down from 83% in the same period in 2022, primarily due to decreased product production in one month of the quarter [39] - The net loss for the quarter was $10.4 million, or a loss of $0.41 per share, compared to a net loss of $6.3 million, or a loss of $0.25 per share in the same period in 2022 [63] Business Line Data and Key Metrics Changes - The increase in commercial revenue was largely driven by broader surgeon usage and deeper penetration, particularly within smaller burn procedures [52] - The company achieved two landmark FDA approvals and a pivotal FDA submission, which are critical for advancing its platform and unlocking growth potential [25] Market Data and Key Metrics Changes - The expansion into trauma centers allows the commercial team to capture a larger portion of the burn market, with an initial target market of approximately 127,000 eligible soft tissue repair procedures and 35,000 eligible burn procedures, representing a total addressable market (TAM) of over $1.2 billion [43] - Japan represents a majority of the foreign revenue line item, with over 90% of international revenue coming from this market [102] Company Strategy and Development Direction - The company is expanding its focus from burn centers to include hospitals, trauma centers, and outpatient settings, with plans to build out its portfolio and explore external business development opportunities [20] - The company is increasing its 2023 annual revenue guidance from $49 million to $51 million, now expecting a range of $51 million to $53 million, reflecting a 53% growth over 2022 at the midpoint of guidance [37][64] Management's Comments on Operating Environment and Future Outlook - Management expressed bullishness about the remainder of the year and 2024, citing early momentum and preparation for new approvals [13] - The company plans to provide 2024 guidance in February 2024, indicating a solid balance sheet and ongoing development of its 2024 plan [51][77] Other Important Information - The company initiated the expansion of its commercial organization, more than doubling its team from 30 to 70, which will result in peak operating expenses as a percentage of revenue in Q3 2023 [47] - The RECELL GO product is expected to significantly ease the burden of training required for physicians and operating room staff, leading to increased adoption across indications [80] Q&A Session Summary Question: Can you provide insight on the broader label secured for soft-tissue data and the potential rethinking of the commercial organization structure? - Management indicated that there are numerous applications under full-thickness skin defects that create a much bigger opportunity, and they plan to assess these before rushing into new initiatives [56] Question: What is the expected timeline for new sales reps to reach productivity levels? - It was noted that new sales reps typically take three to six months to reach cost coverage, with five resale kits per month needed to break even [101] Question: How does the company view margins longer term with the introduction of RECELL GO? - Management expects margins to increase as sales volume grows, potentially approaching 90% margins if sales align with expectations [106] Question: What specific cases are doctors most comfortable with regarding the new indication for full-thickness skin defects? - Management mentioned that cases like degloving and necrotizing fasciitis are being captured quickly, indicating a positive early adoption trend [107]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organizat ...